The clinical evidence of second-generation H1-antihistamines in the treatment of allergic rhinitis and urticaria in children over 2 years with a special focus on rupatadine

ABSTRACT

Introduction

Many obstacles limit the development of pharmacologic studies in children, in particular ethical and practical issues. Therefore, although second-generation H1-antihistamines (sgAH) are recommended by international guidelines as first-line therapy in childhood allergies, most data on the efficacy of antihistamines in children has been extrapolated from studies in adult patients.

Areas covered

The current review focuses on rupatadine, a well-studied modern sgAH that has dual affinity for histamine H1-receptors and PAF receptors. In recent years, clinical efficacy and safety controlled-clinical trials on rupatadine were conducted in children and were based on latest current guidelines using validated tools of allergic rhinitis and urticaria.

Expert opinion

Children are not little adults since they present specific physiologic, metabolic, and developmental differences that should be evaluated in specific trials. The clinical evidence with rupatadine in children is the most recent and validated in accordance with current recommendations, with extensive direct data on efficacy and safety in pediatric populations over 2 years old.

KEYWORDS:

• Rupatadine
• allergic rhinitis
• chronic spontaneous urticaria
• childhood allergies
• PAF antagonist

Article highlights

• International evidence-based guidelines recommend second-generation H1-antihistamines (sgAH) as first option in the treatment of intermittent AR, persistent AR and CSU.

• Recommendations in current guidelines for the treatment of AR or CSU in children are based mainly on extrapolation of data obtained in adults, but clinical data obtained directly in pediatric populations are scarce.

• Although histamine is acknowledged as the main mediator in the pathophysiology of AR and CSU, other mediators such as the platelet activating factor (PAF) play a key role in the allergic reactions.

• Rupatadine is a well-studied sgAH that demonstrated dual affinity for histamine H1- and PAF receptors.

• Many clinical studies confirmed efficacy of rupatadine using data directly obtained in children over 2 years according to current guidelines of allergic rhinitis and urticaria.

• In the future, clinical dosing at ages below 5 years should be based on controlled clinical studies, as this is a group of pediatric patients highly vulnerable due to scarce or incomplete information on both efficacy and safety.

This box summarizes key points contained in the article.

Reviewer disclosures

One referee is or has been a member of the national and international scientific advisory boards (consulting), received fees for lectures, and grants for research projects from Allakos, AstraZeneca, Genentech-Roche, Glenmark, GlaxoSmithKline, Menarini, Merck Sharp and Dohme, Mitsubishi Tanabe, Mylan/Meda Pharma, Novartis, Sanofi-Genzyme & Regeneron, UCB, and the Uriach Group. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Declaration of interest

A Nieto and A Marzon have received grants from Uriach for conducting clinical trials. They have both also received fees for lectures. The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This manuscript was funded by Uriach. This manuscript had writing and editorial assistance provided for by Content Ed Net (Madrid, Spain) which was funded by Uriach.